Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms

September 25, 2022 updated by: Maisa Hashem Mohammed, Sohag University

Oncogenic Role of Engrailed (EN)-2 in Epithelial Ovarian Neoplasms.

Detection of the potential oncogenic role of Engrailed-2 in epithelial ovarian neoplasms, in order to detect biological markers that could be targeted and blocked by new medications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epithelial ovarian carcinomas represent more than 90% of all ovarian carcinomas. Treatment of these ovarian carcinomas on basis of their histopathological features didn't improve patients' outcomes with very high incidence of relapses and resistance to therapy. Detection of novel biological markers which are involved in tumor progression could have promising results if these biological molecules are targeted and blocked by new medications.

Engrailed-2 is a protein encoded by a gene located on chromosome 7. Engrailed-2 is involved in neural development and neural connections during embryological life. it has been proved that Engrailed-2 is expressed in non neural neoplasms, especially in prostatic and urinary bladder carcinomas. Now estimatiion of urinary and serum levels of Engrailed-2 is used as a non-invasive screening tool in to detect prostatic and urinary bladder carcinomas. We aim to evaluated immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues and to compare such expression between normal and neoplastic tissues in order to improve its oncogenic role in ovarian carcinoma.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study will be applied on archived formalin-fixed, paraffin embedded ovarian tissue blocks from women who had ovarian benign, borderline and invasive malignant neoplasms and admitted to Obstetrics and Gynecology Department, Sohag University Hospital where they underwent oophorectomy operations because of benign and/ or malignant indications, from 2015 to 2021.

Description

Inclusion Criteria:

  • All types of epithelial ovarian neoplasms (benign, borderline and malignant).

Exclusion Criteria:

  • Non-epithelial and/ or secondary ovarian tumors.
  • Cases with poor clinical data.
  • Cases who had history of pre-operative chemotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare levels of Engrailed-2 expression in different ovarian specimens.
Time Frame: December, 2021
compare levels of immunohistochemical expression of Engrailed-2 in normal and neoplastic ovarian tissues. and correlate Engrailed-2 expression in neoplastic ovarian tissues to patients' ages, tumor phenotype and state of nodal metastasis.
December, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Maisa H Mohammed, MD, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-09-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the participants will share the statistical analysis record and the informed consent form.

IPD Sharing Time Frame

within six months after publication.

IPD Sharing Access Criteria

the principle investigator will share the statistical analysis record and the informed consent form on her account on research gate.

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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